Ayvakyt

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avapritinib

Authorised
This medicine is authorised for use in the European Union.

Overview

Ayvakyt is a cancer medicine used to treat gastrointestinal stromal tumour (GIST), a cancer of the stomach and bowel, that cannot be removed by surgery and has spread to other parts of the body. Ayvakyt is used when the cancer cells have a D842V mutation, a change in the gene for the platelet-derived growth factor receptor alpha (PDGFRA).

Ayvakyt is also used in adults with advanced systemic mastocytosis, which means any of the following disorders of a type of white blood cell known as mast cells: aggressive systemic mastocytosis, systemic mastocytosis associated with a haematological neoplasm (blood cancer), or mast cell leukaemia. It is used after the patient has received at least one systemic treatment (treatment with medicines affecting the whole body).

These diseases are rare, and Ayvakyt was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 17 July 2017 (GIST) and on 26 October 2018 (mastocytosis).

Ayvakyt contains the active substance avapritinib.

This EPAR was last updated on 18/05/2022

Authorisation details

Product details
Name
Ayvakyt
Agency product number
EMEA/H/C/005208
Active substance
avapritinib
International non-proprietary name (INN) or common name
avapritinib
Therapeutic area (MeSH)
Gastrointestinal Stromal Tumors
Anatomical therapeutic chemical (ATC) code
L01EX18
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

OrphanOrphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Blueprint Medicines (Netherlands) B.V.
Revision
4
Date of issue of marketing authorisation valid throughout the European Union
24/09/2020
Contact address

Gustav Mahlerplein 2
Amsterdam
Netherlands

Product information

24/03/2022 Ayvakyt - EMEA/H/C/005208 - X/0004/G

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

  • Other antineoplastic agents

  • Protein kinase inhibitors

Therapeutic indication

Ayvakyt is indicated as monotherapy for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumours (GIST) harbouring the platelet-derived growth factor receptor alpha (PDGFRA) D842V mutation.

Assessment history

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